{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "192957", "product_res_number": "Z-1042-2022", "event_date_initiated": "2022-03-23", "event_date_created": "2022-05-06", "recall_status": "Open, Classified", "res_event_number": "89935", "product_code": "ONU", "pma_numbers": [ "P140010" ], "product_description": "Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P\tADM04008013P\tADM04008013P\tADM04008013P\tADM04012013P\tADM04015013P\tADM04015013P\tADM04025013P\tADM05004013P\tADM05004013P\tADM05006013P\tADM05006013P\tADM05008013P\tADM05008013P\tADM05020013P\tADM06004013P\tADM06004013P\tADM06006013P\tADM06006013P\tADM06008013P\tADM06012013P\tADM06015013P\tADM06015013P\tADM06015013P\tADM06015013P\tADM07004013P\tADM07006013P\tADM07006013P\tADM07008013P SBI04004013P\tSBI04008008P\tSBI04012013P\tSBI04015013P\tSBI05004008P\tSBI05006013P\tSBI05012008P\tSBI05012008P\tSBI05012013P\tSBI05015013P\tSBI06004008P\tSBI06004008P\tSBI06004013P\tSBI06004013P\tSBI06006008P\tSBI06006008P\tSBI06008008P\tSBI06008008P\tSBI06012013P\tSBI06012013S\tSBI06015013P\tSBI07004013P\tSBI08004013P\tSBI08008008S\tSBI10004008P", "code_info": "Model Number\tLot Number\tGTIN\nADM04004013P\t0010935559\t00643169383500,\nADM04008013P\t0010935575\t00643169383524,\nADM04008013P\t0010935574\t00643169383524,\nADM04008013P\t0010861910\t00643169383524,\nADM04012013P\t0010968204\t00643169383531,\nADM04015013P\t0010891542\t00643169576315,\nADM04015013P\t0010975488\t00643169576315,\nADM04025013P\t0010904889\t00643169975064,\nADM05004013P\t0010861907\t00643169383609,\nADM05004013P\t0010985886\t00643169383609,\nADM05006013P\t0010863869\t00643169383616,\nADM05006013P\t0010954041\t00643169383616,\nADM05008013P\t0010990832\t00643169383623,\nADM05008013P\t0010896018\t00643169383623,\nADM05020013P\t0010904203\t00643169975019,\nADM06004013P\t0010772773\t00643169383258,\nADM06004013P\t0010947006\t00643169383258,\nADM06006013P\t0010968232\t00643169383265,\nADM06006013P\t0010968233\t00643169383265,\nADM06008013P\t0010965798\t00643169383272,\nADM06012013P\t0010891546\t00643169859975,\nADM06015013P\t0010906058\t00643169576353,\nADM06015013P\t0010930866\t00643169576353,\nADM06015013P\t0010900221\t00643169576353,\nADM06015013P\t0010846879\t00643169576353,\nADM07004013P\t0010896015\t00643169383340,\nADM07006013P\t0010863872\t00643169383357,\nADM07006013P\t0010863871\t00643169383357,\nADM07008013P\t0010926488\t00643169383364,\nSBI04004013P\t0011018180\t00763000366513,\nSBI04008008P\t0010735613\t00643169740297,\nSBI04012013P\t0010915831\t00763000366605,\nSBI04015013P\t0010947014\t00643169740440,\nSBI05004008P\t0010947013\t00763000366650,\nSBI05006013P\t0010982240\t00763000366698,\nSBI05012008P\t0010742135\t00643169740396,\nSBI05012008P\t0010947011\t00763000366742,\nSBI05012013P\t0010902109\t00643169740402,\nSBI05015013P\t0010863859\t00643169740464,\nSBI06004008P\t0010735615\t00763000366803,\nSBI06004008P\t0010885373\t00763000366803,\nSBI06004013P\t0010894506\t00643169740181,\nSBI06004013P\t0011018170\t00643169740181,\nSBI06006008P\t0010755363\t00763000366834,\nSBI06006008P\t0010982241\t00763000366834,\nSBI06008008P\t0010885372\t00643169740334,\nSBI06008008P\t0011018176\t00643169740334,\nSBI06012013P\t0011029688\t00643169740426,\nSBI06012013S\t0010875709\t00763000137045,\nSBI06015013P\t0010745656\t00643169740488,\nSBI07004013P\t0010926502\t00643169740204,\nSBI08004013P\t0010742136\t00643169777712,\nSBI08008008S\t0010864424\t00763000136857,\nSBI10004008P\t0010915833\t00643169777880.", "firm_fei_number": "3001452571", "recalling_firm": "Medtronic Vascular, Inc.", "address_1": "3576 Unocal Pl", "city": "Santa Rosa", "state": "CA", "postal_code": "95403-1774", "additional_info_contact": "Medtronic Vascular Customer Service\n800-716-6700", "reason_for_recall": "Packaging for Balloon Catheters may be damaged resulting in loss of sterility.", "root_cause_description": "Packaging process control", "action": "On March 23, 2022 Medtronic issued a \"Urgent: Medical Device Recall\" notification to affected consignees. In addition to informing consignees about the recalled product, Medtronic ask consignees to take the following actions: \n\n1. Identify and quarantine all unused affected IN.PACT Admiral and IN.PACT AV catheters as listed in Table 1.\n\n2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Vascular Customer Service at 800-716-6700 to initiate a product return. Your local Medtronic Representative can assist you with the initiation of the return.\n\n3. Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. \n\n4. This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.", "product_quantity": "6, 035 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, PUERTO RICO, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Croatia\tCyprus, Denmark, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom.", "openfda": { "pma_number": [ "P210039", "P190019", "P130024", "P210025", "P140010", "P160049" ], "device_name": "Drug-Eluting Peripheral Transluminal Angioplasty Catheter", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "3006513822", "3014687026", "1319639", "2011171", "3009380063", "3013556777", "3010273872", "1000121056", "3002807314", "3005111382", "3015190176", "2124215", "1225687", "9681260", "2183744", "2030598", "2134265", "3006946276", "3005994106", "3001374820", "3016257349", "3005969022", "3012102437", "3009999323", "9612164", "2953200", "1313046" ], "fei_number": [ "3006513822", "3014687026", "1000138054", "2011171", "3009380063", "3013556777", "3001452571", "3010273872", "1000121056", "3002807314", "3005111382", "3015190176", "2124215", "2183744", "3006946276", "3005994106", "3001374820", "3016257349", "3005969022", "3012102437", "3002806565", "1000518731", "3009999323", "1313046", "3002806434", "3002095335", "3001451463" ] } } ] }